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FEops HEARTguide ALPACA 3.0.1 / 3.0.2
FEops
3.0.1
Not in Commercial Distribution
- 05430002070063 ()
- Radiology DICOM image processing application software
FEops HEARTguide Simulation Application
FEops
3.0.0
Not in Commercial Distribution
- 05430002070056 ()
05430002070056
- Radiology DICOM image processing application software
FEops HEARTguide™ is indicated for patient-specific simulation of transcatheter left atrial appendage occlusion (LAAO) device implantation during procedural planning.
The software performs computer simulation to predict implant frame deformation to support the evaluation for LAAO device size and placement.
FEops HEARTguide™ is intended to be used by qualified clinicians in conjunction with the simulated device instructions for use, the patient’s clinical history, symptoms, and other preprocedural evaluations, as well as the clinician’s professional judgment.
FEops HEARTguide™ is not intended to replace the simulated device instructions for use for final LAAO device selection and placement.
FEops HEARTguide™ is prescription use only.
FEops
1.4.1
Not in Commercial Distribution
- 05430002070032 ()
- Radiology DICOM image processing application software
Sunrise sensor 2 (single night)
Sunrise
2
In Commercial Distribution
- 05430001896091 ()
A600
- Home-use sleep apnoea recording system
Sunrise sensor 2 (multi-nights)
Sunrise
2
In Commercial Distribution
- 05430001896084 ()
A500
- Home-use sleep apnoea recording system
Sunrise sensor
Sunrise
1
In Commercial Distribution
- 05430001896060 ()
- Home-use sleep apnoea recording system
Sunrise software
Sunrise
1
In Commercial Distribution
- 05430001896015 ()
- Sleep disorder interpretive software, professional-only
No Description
Ectosense
Mini
In Commercial Distribution
- 05430001742039 ()
- 05430001742060 ()
- Home-use sleep apnoea recording system
NightOwl sensor kit.
Ectosense
01.00
In Commercial Distribution
- 05430001742022 ()
- Home-use sleep apnoea recording system
W-Bone is a xenograft biomaterial composed of hydroxyapatite from bovine origin. It is intended to fill, augment, or reconstruct periodontal defects and/or bony defects of the upper or lower jaw.
W-Bone is supplied as a mix of cancellous and cortical particles in a single use thermoformed blister, packaged in a secondary thermoformed blister and sterilized by gamma irradiation.
Wishbone
WHA200
In Commercial Distribution
- 05430001477115 ()
- Weight: 2.0 Gram
- Dental bone matrix implant, animal-derived